Estimating and Reducing the Cardiovascular Risk of Patients With Schizophrenia Drugs From Lipid Measures and Ischemic Electrocardiographic Changes

Northwestern University

Status and phase

Terminated

Phase 3

Conditions

Schizophrenia

Bipolar Disorder

Schizoaffective Disorder

Treatments

Drug: aripiprazole (Abilify)

Drug: ziprasidone (Geodon)

Study type

Interventional

Funder types

Other

Identifiers

NCT00288353

050943

NARSAD

Details and patient eligibility

About

The primary goal of this study is to examine the triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder.

Full description

The primary goal of this study is to examine the triglyceride/HDL ratio and the ischemic EKG changes in patients with schizophrenia, schizoaffective disorder or bipolar disorder. The secondary goal is to identify those subjects in the top tertile for the highest risk of IHD as defined by TG/HDL ratios (>>3.5) and ischemic EKG changes with and without clinical ischemia, e.g. angina and to see if these risk factors can be reduced or reversed by a change of antipsychotic medication, dietary counseling, enrollment into available exercise groups, etc.

Enrollment

250 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

To be eligible, a patient must :

Be male or female, between 18-65.
Have a diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV criteria
Have TG/HDL ratios (>>3.5) and ischemic EKG changes with and without clinical ischemia, e.g. angina
Be treated for a minimum of six months with one of six oral antipsychotic medications: clozapine, haloperidol, olanzapine, quetiapine, risperidone and ziprasidone
Be willing to change current antipsychotic medication to that chosen by the principal investigator
Have a history of compliance with the above medication
Be Medicaid eligible or maintain insurance covering requested lab procedures
Be able to provide written informed consent.

Exclusion criteria

A patient will be considered ineligible if he/she:

Has a diagnosis other than schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria.
Has a history of noncompliance with prescribed psychiatric medications
Has a TG/HDL ratio < 3.5 on current medication
Is uninsured or is unable to self-pay potential costs of required lab procedures not covered by insurance.
Is unable to provide written informed consent.
(Females only) Is pregnant, lactating or plans to become pregnant during study participation